The company said it has received the final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Desonide Cream, 0.05 per cent.
PTI
December 09, 2022 / 11:59 AM IST
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Alembic Pharmaceuticals on Friday said it has received approval from the US health regulator to market Desonide Cream used in treating skin conditions with inflammation and itching in the American market.
The company said it has received the final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Desonide Cream, 0.05 per cent.
The ANDA was filed by Aleor Dermaceuticals (Aleor), which was amalgamated with Alembic, the drug firm said in a statement.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Desonide Cream, 0.05 per cent, of Padagis US LLC.
Desonide Cream, 0.05 per cent, is a low-potency corticosteroid indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
According to IQVIA, Desonide Cream, 0.05 per cent, has an estimated market size of USD 12 million for twelve months ending September 2022.
Alembic said it has now received a cumulative total of 178 ANDA approvals (155 final approvals and 23 tentative approvals) from the USFDA.
